Partners

Clinical Trials Office

The Masonic Cancer Center Clinical Trials Office (CTO) at the University of Minnesota provides the infrastructure necessary to assist investigators in performing high-quality clinical research, insure the validity and integrity of data, and fulfill all National Cancer Institute (NCI) and regulatory requirements.

This infrastructure includes state-of-the-art information systems and database facilities, expertise in the development and management of clinical trials, and development of IND/IDE applications and monitoring plans.

The Clinical Trials Office provides a centralized location for all cancer protocols and associated correspondence with regulatory agencies including the University of Minnesota Institutional Review Board (IRB), National Institutes of Health, FDA, and Cancer Center investigator IND/IDE files.

Responsible Party and ClinicalTrials.govRecently ClinicalTrials.gov clarified the term, Responsible Party (the entity responsible for registering, updating and posting trial results on its public registry), and who has the authority to release these trial records to ClinicalTrials.gov.

In order for the Clinical Trials Office (CTO) to continue providing Principal Investigators (PIs) the service of managing ClinicalTrial.gov submissions, the PIs must delegate this task to the CTO for each of their individual trials.

If not delegated to the CTO, the PI will be responsible for submitting all information required by law to ClinicalTrials.gov. If delegated to the CTO, the CTO will continue, as in the past, to send trial information to you for review prior to submission to ClinicalTrials.gov.

If the CTO has not already contacted you regarding delegating this task, please contact Char Smith, Regulatory Coordinator, Clinical Trials Office at 62-624-9498 or smit4652@umn.edu.

Basic Results Submissions to ClinicalTrials.govIf management of ClinicalTrials.gov submissions has been delegated to the Clinical Trials Office (CTO), CTO staff will work with the Principal Investigator (PI) to initially register and submit updates for the applicable trials.

CTO staff will assist the PI in tracking the dates of final data collection for the pre-specified primary and secondary outcome measures and will notify the PI of the date by which the study results need to be submitted to ClinicalTrials.gov.

CTO staff will work with the PI and biostatistician to obtain the required data and submit to Clinicaltrials.gov in the required format.

Follow-up reminders will be periodically sent to the PI requesting the required data and/or edits to the formatted data. If within 1 month of the results posting due date the CTO does not receive a response from the PI, an email will be sent notifying the PI that the Masonic Cancer Center ClinicalTrials.gov account will be transferred to him or her.

Protocol amendment frequency to be piloted on CETI trialsProtocol amendments for all Cancer Experimental Therapeutics Initiative (CETI) managed investigator-initiated trials will be limited to one amendment per any 6 month period unless the protocol change affects subject safety, eligibility or treatment. This policy is being put into place to help reduce the time and costs involved in amending a protocol and obtaining all necessary regulatory approvals. Requests for protocol revisions can be sent to the Clinical Trials Office Protocol Writer as the need for change is identified. The Protocol Writer will be responsible for collecting and incorporating the revisions into a single protocol amendment.

Protocol TrainingFederal regulations require proof of protocol training before an investigator may conduct any study-related activity.

Starting July 1, 2011, investigators may not obtain consent, begin workup, or enroll a subject on a Clinical Trials Office (CTO)-managed clinical trial until the CTO receives documentation of protocol training.

The simplest way to obtain protocol training is by attending the trial site initiation visit (SIV). Investigators who do not attend the SIV must complete and verify self-training.

The steps for self-training are:

CTO emails the protocol to the investigator.

Investigator reviews the protocol and contacts the Principal Investigator or CTO with any questions.

When the investigator understands the protocol, he or she replies to the original email and indicates he or she has completed training.

Subject Coordinators will verify training documentation is on file when an investigator refers a patient for the trial.